Cosmetic face fillers under review

Videos
Photos

(China Daily)
Updated: 2008-11-19 07:47

The patients are drawn by the allure of ageless beauty.

Unfortunately, for some, the result can be blotchy skin, bumps on the face and worse.

Hundreds of thousands of cosmetic surgery patients are turning to injections of fillers to magically smooth the furrows of aging. Yesterday, the US Food and Drug Administration was asking independent advisers to review the safety of such products, increasingly popular to improve appearance and give a little boost to deflated middle-age egos.

The agency also is seeking guidance on how to improve testing of fillers and more clearly warn patients about potential risks.

Different from Botox, which is derived from a toxin that acts on facial muscles, wrinkle fillers are like the biological equivalent of a bit of spackle - except that they are injected into the face.

FDA officials are concerned that fillers are being used for purposes they were never tested and approved for, such as plumping the lips, which are extremely sensitive.

There are also questions about a lack of clinical evidence on how darker-skinned patients fare with the beauty treatments. More black, Latino and Asian patients are trying plastic surgery, and some information suggests they may be susceptible to unsightly blotches and other complications from fillers.

"The trouble is that once this material is in the hands of physicians, there's really not much control over how it's used and where it's placed," said Dr Scott Spear, a Washington plastic surgeon. "That creates the potential for a certain amount of mischief.

"But the good news is that, by and large, these are very safe materials," he added. "They have a very healthy risk profile."

FDA scientists will present the advisory panel with data on 823 patients who suffered reactions after treatment with fillers between 2003 and this September. The overwhelming majority were women, and the most common age group was 50- to 60-year-olds. Plastic surgeons performed more than 1 million cosmetic surgery procedures with fillers last year alone.

Although no deaths were reported to the FDA, the complications were troublesome enough that 638 of the patients required follow-up medical treatment.

Most reactions involved minor swelling and redness, complications that could be expected. But the FDA said it also received reports of "serious and unexpected" problems, including facial, lip and eye paralysis, disfigurement, vision complications and some severe allergic reactions.

Agencies

(China Daily 11/19/2008 page10)